Standard or Low Dose Alteplase in Acute Ischemic Stroke–Does It Matter?

MedicalResearch.com Interview with:

Craig Anderson | MD PhD FRACP Executive Director  Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China

Prof. Anderson

Craig Anderson | MD PhD FRACP
Executive Director
Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney
Neurologist, Neurology Department, Royal Prince Alfred Hospital
The George Institute for Global Health at Peking University Health Science Center
Haidian District | Beijing, 100088 P.R. China

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago.  The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design.

The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain.  However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery.

The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment.  We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain.

The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups.  Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied.

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Genetic Testing Reduces Risk Of Side Effects From Anticoagulation After Surgery

MedicalResearch.com Interview with:

Anne R. Bass, MD Associate Professor of Clinical Medicine Weill Cornell Medical College Rheumatology Fellowship Program Director Hospital for Special Surgery New York, NY 10021

Dr. Bass

Anne R. Bass, MD
Associate Professor of Clinical Medicine
Weill Cornell Medical College
Rheumatology Fellowship Program Director
Hospital for Special Surgery
New York, NY 10021

MedicalResearch.com: What is the background for this study?

Response: Blood thinners are used after orthopedic surgery to prevent blood clots from forming in the legs and traveling to the lungs. They are also used in patients with certain heart diseases to prevent strokes. Blood thinners, like warfarin, are effective but can be associated with serious bleeding complications, especially if the wrong dose is given. Genetic testing can help doctors predict the right warfarin dose to use in an individual patient.

In this trial, ≈1600 elderly patients undergoing hip or knee replacement were randomly assigned to receive warfarin dosing based on genetics plus clinical factors (like height, weight and gender), or based on clinical factors alone. The specific genes tested wereVKORC1, CYP2C9, and CYP4F2 which influence warfarin metabolism and the body’s ability to produce clotting factors.

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Phase 3 Study Finds XARELTO® Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots in VTE

MedicalResearch.com Interview with:

Paul Burton, MD, PhD, FACC Vice President, Medical Affairs Janssen

Dr. Paul Burton

Paul Burton, MD, PhD, FACC
Vice President, Medical Affairs
Janssen

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all.

The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups.

These results were presented at the American College of Cardiology’s 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine.

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Computerized Clinical Decision Support Systems Can Reduce Rate of Venous Thromboembolism

MedicalResearch.com Interview with:
Zachary Borabm, Research fellow

Hansjörg Wyss Department of Plastic Surgery
NYU Langone Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Recent studies have shown that health care providers perform poorly in risk stratifying their patients for venous thromboembolism (VTE) which leads to inadequate VTE prophylaxis delivery, especially in surgical patients. Computerized Clinical Decision Support Systems (CCDSSs) are programs integrated into an electronic health record that have the power to aid health care providers. Using a meta-analysis study technique we were able to pool data from 11 studies, including 156,366 patients that either had CCDSSs intervention or routine care without CCDSSs.

Our main outcome measures were the rate of prophylaxis for VTE and the rate of actual VTE events. We found that CCDSSs increased the rate of VTE prophylaxis (odds ratio 2.35, p<0.001) and decreased the risk of VTE events (risk ratio 0.78, p<0.001).

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Pradaxa: Compared To Warfarin, Lower Risk of Stroke and Bleeding in Non-Valvular AFib

MedicalResearch.com Interview with:

Sabine Luik, M.D. Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Sabine Luik

Sabine Luik, M.D.
Senior vice president, Medicine & Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Data from more than 20,000 patients with non-valvular atrial fibrillation (NVAF) were included in this study and the results demonstrate that Pradaxa® (dabigatran etexilate mesylate) was associated with a lower risk of stroke and major bleeding compared to warfarin. The study analyzed 7,245 PRADAXA patients and 14,490 warfarin patients with NVAF who had no prior use of an oral anticoagulant (OAC), using data from an administrative claims database from October 1, 2010, to April 30, 2014.

Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). PRADAXA was associated with a lower risk for serious secondary outcomes, including a 68 percent reduced risk of hemorrhagic stroke (HR, 0.32; 95% Cl, 0.14-0.76), an 18 percent reduced risk of major extracranial bleeding (HR, 0.82; 95% Cl, 0.70-0.96), a 48 percent reduced risk of venous thromboembolism (HR, 0.52; 95% Cl, 0.38-0.70), and a 27 percent reduced risk of death (HR, 0.73; 95% Cl, 0.61-0.88).

MedicalResearch.com: What should readers take away from your report?
Response: These results support the benefits of PRADAXA therapy for patients with NVAF and are consistent with those of previous studies evaluating PRADAXA and warfarin. Through a robust clinical trial, Pradaxa was proven superior to warfarin in reducing the risk of stroke in patients with NVAF.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Real-world data are critical for improving our understanding of treatment for patients with chronic conditions such as NVAF. We believe by working with diverse stakeholders to continue to study PRADAXA in the real world, we can help the community better understand gaps in treatment, identify opportunities to improve care and increase patient and physician assurance in treatment decisions.

MedicalResearch.com: Is there anything else you would like to add?

Response: Pradaxa has the longest real-world experience of any available NOAC. This research includes seven clinical trials with more than 32,000 patients and real-world experience through 11 studies and assessments, including more than 120,000 PRADAXA patients with NVAF.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

INTERNATIONAL STROKE CONFERENCE ORAL ABSTRACTSSESSION TITLE: PREVENTIVE STRATEGIES ORAL ABSTRACTS
Abstract 75: Bleeding and Ischemic Stroke Risk in Patients with Atrial Fibrillation Standard or Low Dose Dabigatran and Concomitant P-gp Inhibitors
Mary Vaughan Sarrazin, Alexander Mazur, Michael P Jones, Elizabeth Chrischilles
Stroke. 2017;48:A75

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Statins Linked to Reduced Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab) Research Fellow/Epidemiologist Musculoskeletal Research Unit University of Bristol School of Clinical Sciences Learning & Research Building (Level 1) Southmead Hospital

Dr. Setor Kunutsor

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab)
Research Fellow/Epidemiologist
Musculoskeletal Research Unit
University of Bristol
School of Clinical Sciences
Southmead Hospital

MedicalResearch.com: What is the background for this study?

Response: Statins are well established for the prevention of cardiovascular disease and this is based on their ability to lower levels of circulating lipids in the blood. However, statins are also known to have pleotropic effects and these include potential protective effects on multiple disease conditions.

Based on their anti-inflammatory and antithrombotic properties, there have been suggestions that statins may prevent venous thromboembolism (VTE) (which comprises of pulmonary embolism and deep vein thrombosis). The evidence is however uncertain. Several studies utilizing both observational cohort and randomized controlled designs have been conducted to evaluate whether statin therapy or use is associated with a reduction in the incidence of VTE, but the results have been inconclusive. In a recent review that was published in 2012, Rahimi and colleagues pooled the results of several randomized controlled trials (RCTs), but found no significant reduction in the risk of VTE with statin therapy [REF]. Given the publication of new studies since this study was published and the existing uncertain evidence on the effect of statins on VTE, we decided it was time to bring all the evidence together and evaluate if statin therapy really did have a protective effect on the risk of venous thromboembolism.

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Only High Risk Patients May Require Anticoagulation After Arthroscopic Knee Surgery

MedicalResearch.com Interview with:

Suzanne C. Cannegieter, M.D., Ph.D. Einthoven Laboratory  Leiden University Medical Center  The Netherlands

Dr. Suzanne Cannegieter,

Suzanne C. Cannegieter, M.D., Ph.D.
Einthoven Laboratory
Leiden University Medical Center
The Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients who undergo arthroscopic knee surgery and patients who are treated with casting of the lower leg are at increased risk for venous thromboembolism (VTE). It is uncertain whether thromboprophylaxis is effective in these situations to prevent VTE. For both indications, several trials have been performed to evaluate the effectiveness of anticoagulant prophylaxis. However, an overall risk–benefit balance could not be established because of methodologic shortcomings; hence, there has been reluctance to establish international guidelines regarding the use of anticoagulant therapy for either of these indications.

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Starting Testosterone Associated With Increased Risk of Blood Clots

MedicalResearch.com Interview with:
Dr. Carlos Martinez

Institute for Epidemiology, Statistics and Informatics GmbH
Frankfurt, Germany,

MedicalResearch.com: What is the background for this study?

Response: A 10-fold increase in testosterone prescriptions per capita in the United States and a 40-fold increase in Canada in men has occurred over the first decade of this century, mainly for sexual dysfunction and/or decreased energy. Recognised pathological disorders of the male reproductive system remain the sole unequivocal indication for testosterone treatment but there has been increasing use in men without pathological hypogonadism. A variety of studies and meta-analyses have provided conflicting evidence as to the magnitude of the risk of cardiovascular events including venous thromboembolism in men on testosterone treatment.

In June 2014, the US Food and Drug Administration and Health Canada required a warning about the risk of venous thromboembolism to be displayed on all approved testosterone products. Studies have reported contradictory results on an association between testosterone use and the risk of venous thromboembolism. The effect of timing and duration of testosterone use on the risk of venous thromboembolism was not studied and may explain some of these contradictory findings.

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Peripheral IV Lines Linked To Lower Risk of Blood Clots After Transfusion

MedicalResearch.com Interview with:
Mary A.M. Rogers, PhD, MS

Research Associate Professor
Research Director, Patient Safety Enhancement Program
Department of Internal Medicine
University of Michigan
Ann Arbor, MI

MedicalResearch.com: What is the background for this study?

Response: Peripherally inserted central catheters (PICCs) are commonly used for vascular access in hospitalized patients. Previous studies have shown that PICCs of larger gauge (diameter) increase the risk of developing venous thromboembolism (blood clots in the deep veins that sometimes travel to the lung). Red blood cell transfusion is also known to increase the risk of venous thromboembolism. Because PICCs are often used to transfuse blood, we designed a study to investigate whether the method of transfusion delivery influences the risk of developing venous thromboembolism.

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Laser-Assisted Technology Allows Easier Removal of IVC Filters

MedicalResearch.com Interview with:

William T. Kuo, MD, FSIR, FCCP, FSVM Director, Stanford IVC Filter Clinic Director, IR Fellowship Program Founding Director, IR-DR Residency Program Associate Professor, Interventional Radiology Stanford University Medical Center Stanford, CA

Dr. William T. Kuo

William T. Kuo, MD, FSIR, FCCP, FSVM
Director, Stanford IVC Filter Clinic
Director, IR Fellowship Program
Founding Director, IR-DR Residency Program
Associate Professor, Interventional Radiology
Stanford University Medical Center
Stanford, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In the USA, over 250,000 IVC filters are now implanted each year, and rising filter use has led to an increase in filter-related morbidity and recognition of the potential complications from indwelling IVC filters. Consequently, the FDA has issued two safety communications alerting all physicians caring for patients with IVC filters to consider removing the filter as soon as protection from pulmonary embolism is no longer needed:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm?so urce=govdelivery&utm_medium=email&utm_source=govdelivery

Despite heightened awareness, up to 40-60% of IVC filters cannot be easily removed using standard methods alone, after the filter becomes firmly embedded. Additionally, many patients have undergone prior placement of a permanent-type filter not even designed for retrieval, leaving them with few options for safe device removal. Although all of these patients can develop filter-related morbidity especially after chronic implantation, there is currently no routine option for removing embedded IVC filters refractory to standard retrieval methods. Our 5-year first-in-human study of a novel procedure—laser-assisted filter removal— demonstrates the safety and efficacy of this technique to treat such patients. In a cohort refractory to standard retrieval methods and high force, endovascular laser-assisted retrieval was overall safe and successful in removing a variety of filter types including permanent filters, regardless of dwell time and without the need for open surgery.

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Shorter Hospital Stays and Lower Costs for Rivaroxaban Compared With Warfarin for Venous Thrombosis Admissions

MedicalResearch.com Interview with:
Truven Health AnalyticsJay Margolis, PharmD
Sr. Research Scientist
Truven Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Vitamin K antagonists (VKAs), most commonly warfarin, had been the only orally available anticoagulants available for the last 60 or so years. While highly effective, use of these agents was often problematic due to their narrow therapeutic index, need for routine coagulation monitoring, and interactions with food and other drugs. Recently introduced new oral anticoagulants (NOACs), particularly rivaroxaban, had been shown in clinical trials to provide comparable efficacy to the VKAs without the need for routine coagulation monitoring. There have been few studies outside of clinical trials showing benefits that translate to real-world populations.

In our study using real-world data from a large sample of geographically and demographically diverse US hospitals, patients hospitalized for incident venous thromboembolisms (VTE) initiating oral anticoagulant treatment with rivaroxaban had significantly shorter hospital stays and lower hospitalization costs compared with warfarin-treated patients.

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Use of Oral Anticoagulation at Time of PCI Surgery Linked To Increase in Adverse Events

MedicalResearch.com Interview with:

Eric A. Secemsky, MD MSc Interventional Cardiology Fellow Massachusetts General Hospital, Harvard Medical School Fellow, Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center

Dr. Eric A. Secemsky

Eric A. Secemsky, MD MSc
Interventional Cardiology Fellow
Massachusetts General Hospital
Harvard Medical School
Fellow, Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center

MedicalResearch.com: What is the background for this study?

Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown.

Therefore, we used PCI data from a large, integrated healthcare system to determine current use of  oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy.

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Mechanism of Injury Makes A Difference In Risk of Venous Thromboembolism

MedicalResearch.com Interview with:
Charles A. Karcutskie IV, MD, MA

Postdoctoral Research Fellow
University of Miami Miller School of Medicine
Department of Surgery
Divisions of Trauma, Surgical Critical Care, and Burns

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our research group at the Ryder Trauma Center have recently done several studies showing various differences in outcomes and risk based on mechanism of injury. Additionally, venous thromboembolism (VTE) is another topic that our group has focused on in the past several years. Because trauma patients are inherently at a higher risk for VTE due to the nature of their injury, we questioned whether the most important risk factors for VTE were different after blunt or penetrating trauma. At our institution, we assess VTE risk with the Greenfield Risk Assessment Profile, which is a list of several risk factors that each have weight toward an overall risk score. We took these risk factors and analyzed them individually based on mechanism of injury. We found that the factors that contribute to the VTE risk are different based on injury mechanism: After blunt trauma, transfusion status, neurologic status, and pelvic fracture contributed most. After penetrating trauma, vascular injury, severe abdominal injury, and age 40-59 years contributed most. This tells us that mechanism of injury may need to be incorporated into the risk assessment in order to discover the highest risk patients.

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C-section carries a 4-fold increased risk of blood clots, compared with vaginal deliveries

MedicalResearch.com Interview with:
Marc Blondon, MD
Division of Angiology and Hemostasis, Department of Specialties of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland
Seattle Epidemiologic Research and Information Center, Department of Veterans Affairs Office of Research and Development, Seattle, WA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism, a condition including deep vein thrombosis (blood clots) and pulmonary embolism, is more common in older than younger patients. However, pregnancy and particularly the postpartum period are times at greater risk of blood clots in women. It is important to understand the risk and the risk factors for thrombosis in the postpartum period to guide the use of preventive measures such as heparin, an anticoagulant treatment, or leg compression devices.

Our study summarizes the evidence on the link between C-sections and blood clots from the past 35 years.
Our meta-analysis demonstrates that:

  • C-section carries a 4-fold increased risk of blood clots in the postpartum period, compared with vaginal deliveries ;
  • that this risk is most prominent but not restricted to emergency C-section ;
  • and that women who undergo elective C-section are also at higher risk than women who have a vaginal delivery.
  • Importantly, we estimated an absolute risk of blood clots after a C-section of 2-4 per 1000 pregnancies: on average, 3 out of 1000 women after C-section will develop a blood clot.

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The GLORIA-AF Registry: Two Year Follow Up of Dabigatran for Non-Valvular A Fib Reported

MedicalResearch.com Interview with:

Menno Huisman, MD, PhD Associate professor Department of Medicine Leiden University Medical Center The Netherlands

Dr. Menno Huisman

Menno Huisman, MD, PhD
Associate professor
Department of Medicine
Leiden University Medical Center
The Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotic agents in real-world clinical practice. The program is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different regimens for stroke prevention.

At the ESC Congress 2016, we presented the first Phase II results of GLORIA-AF from approximately 3,000 NVAF patients, which showed that treatment with PRADAXA was associated with low incidences of stroke, major bleeding and life threatening bleeding. Less than 1% of PRADAXA-treated patients experienced a stroke over two years (0.63%). Major bleeding occurred in 1.12% of PRADAXA-treated patients and 0.54% experienced a life-threatening bleed.

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Complex Stent Procedures May Require Longer Period of Antiplatelet Therapies

MedicalResearch.com Interview with:

Gennaro Giustino MD Resident Physician - Department of Medicine The Icahn School of Medicine at Mount Sinai

Dr. Gennaro Giustino

Gennaro Giustino MD
Resident Physician – Department of Medicine
The Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study?

Response: A period of dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The pathophysiological rationale for DAPT after DES-PCI is predicated on the need to prevent stent-related thrombotic complications while vascular healing and platform endothelialization are ongoing, a process that seems to last between 1 and 6 months with new-generation DES. Whether to extend DAPT after this mandatory period in order to provide a broader atherothrombotic risk protection (for stent-related and non-stent-related atherothrombotic events) is currently a matter of debate. Current guidelines recommend at least 6 months of DAPT after PCI in patients with stable coronary artery disease (CAD) and at least 12 months of DAPT in patients presenting with acute coronary syndrome (ACS). While, several risk scores have been developed to guide clinical decision making for DAPT intensity and duration (namely the DAPT score and the PARIS risk scores) little attention has been payed so far to PCI complexity and the extent of CAD to guide duration of DAPT. In fact irrespective of clinical presentation, patients undergoing more complex PCI procedure (likely due to greater coronary atherosclerotic burden) may remain at greater risk for ischemic events and therefore may benefit of prolonged, or more intense, DAPT.

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Intracoronary Antiplatelet Abciximab Bolus May Improve Outcomes of Primary PCI in STEMI patients with Diabetes

MedicalResearch.com Interview with:
Raffaele Piccolo, MD
Department of Cardiology
Bern University Hospital
University of Bern
Bern, Switzerland

MedicalResearch.com: What is the background for this study?

Response: Over the past two decades, the prevalence of diabetes mellitus has doubled in Western countries and future projections are even worse by showing a 55% increase by 2035 when approximately 592 million of people are expected to live with diabetes all over the world.

Acute myocardial infarction still represents the most common diabetes-related complication and its occurrence is associated with a higher risk of mortality. Timely recanalization of the occluded coronary vessel with primary percutaneous coronary intervention (PCI) represents the therapy of choice for acute ST-segment elevation myocardial infarction (STEMI).

Our study investigated whether the direct application of an intracoronary bolus of abciximab, which is an antiplatelet drug blocking the glycoprotein IIb/III a receptor, at the time of primary PCI improves the outcomes at 1-year follow-up compared with the standard intravenous route. The study was in individual patient-level pooled analysis of 3 randomized trials including 2,470 patients, of whom 473 (19%) had diabetes.

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Proove Biosciences Introduces Genetic Tests To Complement Pain and Thromboembolism Care

Brian Meshkin Founder and CEO of Proove Biosciences

Brian Meshkin

MedicalResearch.com Interview with:
Brian Meshkin
Founder and CEO of Proove Biosciences

Editor’s note: Proove Biosciences, Inc introduced three new evidence-based tests to support better clinical decision-making for difficult-to-treat conditions that are influenced by genetics. These conditions include substance abuse, fibromyalgia and venous thromboembolism. The tests are especially relevant in light of the House of Representatives passing the Comprehensive Addiction Recovery Act (CARA) bill on July 8, 2016 to combat the opioid epidemic.

MedicalResearch.com: Would you update our readers on the significance and implications of the CARA Act? What is the role of genetics in addiction? What is the background for the Proove Addiction™ Profile? How does it aid in addiction management?

Response: CARA is a national piece of legislation to expand access to treatment for drug overdoses and addiction. It also includes some other provisions meant to help address the opioid epidemic. However, there are some serious implications.

First, it does not contain any funding, so it is a bit of a “Potemkin Village”. It is also a bit of a façade because it does not address 50% of the equation. According to the definition of addiction from the American Society of Addiction Medicine (ASAM) and the National Institutes of Drug Abuse (NIDA), about half of substance abuse is due to genetic factors. If you are studying for a test and ignoring half of the material, chances are you are not going to do well on the test. As doctors are confronted with the challenges of objectively assessing pain and knowing which patients are at risk for abuse, they must consider genetics.

The Proove Opioid Risk test combines genetic markers and phenotypic variables into an algorithm to effectively identify patients at low, moderate and high risk for opioid abuse. By knowing this information, a physician can make better decisions about opioids. For low risk patients, a physician can safely prescribe and a patient does not need to fear the opioid prescription they are given – as this is about 50% of the population. For those at moderate risk, a physician can use a greater level of vigilance to monitor those patients with abuse-deterrent formulations, regular urine drug screens, opioid contracts, and other tools to monitor their use. For the small number of patients – less than 10% – that are at high risk, a physician can use alternative forms of pain relief such as interventional procedures or non-opioid analgesics to provide the needed relief to patients.

The Proove Addiction Profile builds on this commitment, by providing genetic data points related to other disorders, such as addictions to alcohol, heroin, cocaine and others. Unfortunately, many patients who screen positive for aberrant behavior, such as having an illicit drug in their urine, are often discharged from care by their doctor. This just gets them lost in the system. By running the Proove Addiction Profile in addition to a urine drug screen, a doctor can better understand the genetic factors associated with the aberrant behavior and refer the troubled patient to an addiction specialist for treatment.

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Compression Stockings May Not Reduce Post Thrombotic syndrome in DVT Patients

MedicalResearch.com Interview with:

Riyaz Bashir MD, FACC, RVT Professor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140

Dr. Riyaz Bashir

Riyaz Bashir MD, FACC, RVT
Professor of Medicine
Director, Vascular and Endovascular Medicine
Department of Medicine
Division of Cardiovascular Diseases
Temple University Hospital
Philadelphia, PA 19140

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Bashir: The use of compression stockings in the prevention of post thrombotic syndrome following an episode of deep vein thrombosis is common in clinical practice. However, the evidence to suggest its efficacy has been put into question by the recent publication of the SOX trial. Since this was the largest randomized controlled trial to date addressing this issue, it has led to clinicians questioning whether compression stockings should be used at all in these patients.

The main finding of this meta-analysis was that in patients with deep venous thrombosis, use of elastic compression stockings does not significantly reduce the development of post thrombotic syndrome. However the current body of evidence is limited and we believe at present it is too early to give up on the use of this therapy, which may benefit many subgroups of patients.

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IVC Filters Widely Used in Attempt To Prevent Pulmonary Embolism

MedicalResearch.com Interview with:

Behnood Bikdeli MD Department of Internal Medicine and Center for Outcomes Research and Evaluation (CORE) Yale University School of Medicine New Haven, CT 06510

Dr. Behnood Bikdeli

Behnood Bikdeli MD
Department of Internal Medicine and Center for Outcomes Research and Evaluation (CORE)
Yale University School of Medicine
New Haven, CT 06510 

Medical Research: What is the background for this study? What are the main findings?

Response: The idea of closing the path of inferior vena cava (IVC) to prevent blood clots migrating to the pulmonary circulation and causing a pulmonary embolism (PE) has been around for over 150 years. We were aware than many practitioners might think of IVC filters for that reason, and specifically with the introduction of retrievable filters in recent years; that have made it more palatable for referring physicians.

However, there is a paucity of high-quality data to suggest the efficacy of IVC filters. The two existing large trials did not show a mortality benefit from use of filters, and the guidelines have very narrow indications for use of IVC filters in patients who have already had a pulmonary embolism.

Having said that, we wondered whether despite the absence of high-quality comparative effectiveness data, filters might be commonly used in patients with PE, particularly among older adults who are a vulnerable population (at higher risk of PE, at higher risk of PE complications; but also less likely to receive other advanced therapies for PE).

Our study common use of IVC filters among older adults in the US; with over 75% relative increase in use of IVC filters from 1999 to 2010 (from ~5000 patients with PE in 1999 to ~9000 patients with PE in 2010). We also noted wide regional variations in the use of IVC filters (e.g. highest in the South Atlantic and lowest in the Mountain region). Such differences fundamentally persisted over time. In addition, we noted declining short-term and 1-year mortality rates in patients with pulmonary embolism over time, irrespective of whether or not they received an IVC filter.

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Does Metabolizer Status Matter in Acute Coronary Syndromes Treated With Prasugrel vs Clopidogrel?

MedicalResearch.com Interview with:

Professor Keith AA Fox Duke of Edinburgh Professor of Cardiology University of Edinburgh

Prof. Keith Fox

Professor Keith AA Fox
Duke of Edinburgh Professor of Cardiology
University of Edinburgh

Medical Research: What is the background for this study?

Prof. Fox: From previous reports, certain alleles of CYP2C19 are associated with reduced enzymatic function and reduced conversion of clopidogrel to the active metabolite. Patients carrying these reduced function alleles (reduced metabolizers) exhibit higher platelet reactivity when treated with clopidogrel, compared with patients without reduced-function alleles (extensive metabolizers). However, the relationship of CYP2C19 genotype and outcomes in medically managed patients with acute coronary syndromes (ACS) is not known.

Medical Research: What are the main findings?

Prof. Fox: There was no association between CYP2C19 metabolizer status (EM vs. RM) and the primary composite endpoint of cardiovascular death, myocardial infarction (MI), or stroke (hazard ratio [HR]: 0.86). EM and RM patients had similar rates of the primary endpoint whether treated with prasugrel (HR: 0.82) or clopidogrel (HR: 0.91; p for
interaction non significant).

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What Normalizes Bleeding Time Best After Coumadin Related Brain Bleed?

MedicalResearch.com Interview with:

Thorsten Steiner, MD, PhD Klinikum Frankfurt Hoechst and Heidelberg University Hospital Germany

Dr. Thorsten Steiner

Thorsten Steiner, MD, PhD
Klinikum Frankfurt Hoechst and Heidelberg University Hospital
Germany

Medical Research: What is the background for this study? What are the main findings?

Dr. Steiner: Background of the study is intracranial hemorrhage (ICH) related to vitamin-K antagonists. The mortality rate is about 60%. Main reason for the high mortality rate is hematoma expansion which occurs in about 50% during the acute phase right after the start of symptoms. We performed an investigator initiated randomized controlled trial (RCT) and found that a 4-factor prothrombin complex (PCC) is superior to fresh frozen plasma (FFP) in normalizing the international normalized ratio (INR) and prevents hematoma expansion. This let to more deaths within 48 hours in the FFP-group but had no clinical impact at 3 months – but our study was powered to detect INR normalization and not a clinical endpoint.
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Is the Evidence for the Anticoagulant Rivaroxaban Valid?

MedicalResearch.com Interview with:

Dr. Deborah Cohen

Dr. Deborah Cohen

Dr. Deborah Cohen
Associate Editor BMJ
BMA House, Tavistock Square
London

Medical Research: What is the background for this study? What are the main findings?

Dr. Cohen: Anyone familiar with warfarin understands the critical role of INR values in determining the proper dose for warfarin patients. The INR value in an individual patient is the most important piece of information a doctor considers when determining the warfarin dose. If the doctor gives too little warfarin then the patient may be at undue risk of stroke; if too much, the patient may be at undue risk of a major bleed.

The BMJ investigation revealed that the INR device used to manage the ~7,000 warfarin patients in the ROCKET trial (which served as the basis for approval of the non-valvular atrial fibrillation indication) was defective.

As such – doctors were relying upon a defective device in determining the dose of the warfarin patients – which has a direct influence on the stroke and bleeding risk in that patient. Since this was a comparative trial – any deficiency in the performance of the comparator arm (warfarin) would skew the results in favour of the study drug (rivaroxaban).

Since INR directly influences strokes and bleeds – the primary efficacy and safety endpoints – it very much questions, if not undermines, the overall results of this trial.

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Incomplete Follow Up Rates Exceed 10% in Oral Antithrombotic Trials

Victor Serebruany, MD, PhD HeartDrug Research, Towson, Maryland Department of Neurology Johns Hopkins University Baltimore, Maryland

Dr. Victor Serebruany

MedicalResearch.com Interview with:
Victor Serebruany, MD, PhD
HeartDrug Research, Towson, Maryland
Department of Neurology Johns Hopkins University Baltimore, Maryland

Medical Research: What is the background for this study? What are the main findings?

Dr. Serebruany: Missing data are common challenges to the validity of trial results, yet it is unclear how to characterize the extent of missing data.  We compared the published lost-to-follow-up rates to incomplete follow-up rates determined from subject records submitted to the FDA for major oral antithrombotic trials.  The 21 trials having both sets of rates included 270,089 patients followed for a median duration of 20 months.  The mean published lost-to-follow-up rates is 0.4% (median 0.3%, range 0.005% to 2%), consistently much lower than the FDA incomplete follow-up rates: mean 12% (median 13%, range 2% to 23%).  There is no correlation between the publication and FDA-calculated  rates (R 0.07, p = 0.76).   The FDA rates exceed greatly the endpoint rate differences: mean 1.3% (median 1,0%, range 0.2% to 3.0%).

Medical Research: What should clinicians and patients take away from your report?

Dr. Serebruany: That the FDA incomplete follow-up rates greatly exceed the endpoint rate differences raises questions of whether the endpoint differences may be due to differential follow-up rather than drug effect.  That they greatly exceed the measures routinely reported for trials, i.e., lost-to-follow-up rates, suggests that current trial reporting is inadequate.  Completeness of follow-up and other indicators of trial data quality should be considered when interpreting trial results.

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Study Finds Women Who Take Anticoagulants Can Use Hormonal Therapy

Ida Martinelli MD, PhD A Bianchi Bonomi Hemophilia and Thrombosis Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Italy

Dr. Martinelli

MedicalResearch.com Interview with:
Ida Martinelli MD, PhD
A Bianchi Bonomi Hemophilia and Thrombosis Center
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Milan, Italy 

Medical Research: What is the background for this study? What are the main findings?

Dr. Martinelli: Hormonal therapies are associated with an increased risk of venous thromboembolism. Patients with acute deep-vein thrombosis or pulmonary embolism require anticoagulation, but women of childbearing potential require also an adequate contraception, as oral anticoagulants cross the placenta potentially leading to embryopathy or fetal bleeding. This study was aimed to evaluate the safety of hormonal therapies together with anticoagulant therapies in terms of recurrent venous thrombosis and uterine bleeding. We demonstrated for the first time that women who take oral anticoagulants can safely use hormonal therapies, as their risk of recurrent venous thromboembolism or uterine bleeding is not increased.

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Pre-op Venous Thromboembolism Prophylaxis Safely Reduced Clots and Pulmonary Emboli

MedicalResearch.com Interview with:
Luke V. Selby, MD
Research Fellow, Department of Surgery
Vivian E. Strong, MD FACS
Associate Attending Surgeon, Department of Surgery
Memorial Sloan Kettering Cancer Center

Medical Research: What is the background for this study? What are the main findings?

Response: There was strong concern at our institution about the safety of providing pre-operative Venous Thromboembolism (VTE) chemoprophylaxis (in addition to our standard peri and post-operative prophylaxis) was unsafe.  To answer this question we administered a single dose of either low molecular weight heparin or unfractionated heparin to all eligible surgical patients at our institution over a six month period. When compared to identically selected patients operated on during the preceding 18 months, patients who received the pre-operative VTE chemoprophylaxis did not have higher rates of bleeding complications and had lower rates of DVT and pulmonary embolism (PE).

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Infections Can Induce Widespread Blood Clotting

MedicalResearch.com Interview with:
Professor Adam Cunningham PhD
Institute of Immunology and Immunotherapy
MRC Centre for Immune Regulation
University of Birmingham

Medical Research: What is the background for this study?

Dr. Cunningham: Our original question was “Why do people die from Salmonella infections that spread beyond the gut”. Some reasons are known but these do not account for all. In particular infants in sub-Saharan Africa seem particularly prone to Salmonella infections that in the West do no more than cause a self-limiting gastroenteritis. A puzzling feature of many of infections in such infants is that they do not have many bacteria in the blood, probably <10 / ml of blood, yet this low density is a strong predictor of death. Therefore, we thought that it may be the host response to the infection that complicates its control and contributes.

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Model Predicts Risk of Blood Clots in Patients With Cast on Leg

MedicalResearch.com Interview with:
Banne Nemeth, MD and  Suzanne C. Cannegieter MD PhD
Leiden University Medical Center
The Einthoven Laboratory for Experimental Vascular Medicine
Clinical Department of Epidemiology and Orthopedic Surgery

Medical Research: What is the background for this study? What are the main findings?

Dr. Nemeth: Clinicians cannot currently accurately predict who will develop venous thrombosis, but it would be very helpful to be able to identify individuals at high risk for venous thrombosis because the condition can be prevented by giving anticoagulants before a clot forms (thromboprophylaxis). The ability to predict venous thrombosis would be particularly useful in patients who have had a lower limb immobilized in a cast after, for example, breaking a bone. These patients have an increased risk of venous thrombosis compared to patients without cast immobilization.

We developed and validated a prediction model to identify patients with plaster cast of the lower extremity who are at high risk to develop venous thrombosis. A clinical risk score named, L-TRIP(cast) score (Leiden Thrombosis Risk Prediction for patients with cast immobilization score), was developed containing 14 clinical risk factors such as age, sex, BMI, use of oral contraceptives and location of plaster cast. Patients that score 9 points or higher are classified as being at high risk for venous thrombosis. Clinicians may decide to prescribe thromboprophylaxis therapy for these patients.

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For Medicare Patients, Dabigatran Offers Significant Cost Savings Over Warfarin

Geoffrey Barnes, MD, MSc Clinical Lecturer Cardiovascular Medicine and Vascular Medicine University of Michigan Health System

Dr. Barnes

MedicalResearch.com Interview with:
Geoffrey Barnes, MD, MSc
Clinical Lecturer
Cardiovascular Medicine and Vascular Medicine
University of Michigan Health System

Medical Research: What is the background for this study?

Dr. Barnes: Although warfarin has been the primary anticoagulant used for stroke prevention in atrial fibrillation for over 60 years, four new direct oral anticoagulants (DOACs) have been introduced into the market since 2010. Dabigatran, which directly inhibits thrombin, was found to have better prevention of ischemic stroke and a significant reduction in hemorrhagic stroke (bleeding strokes) for patients with atrial fibrillation at intermediate and high risk of stroke.  Prior cost-effectiveness studies have shown that dabigatran is cost-effective from both the societal and payer (usually Medicare) perspectives.  However, none of those studies looked at the patient’s out-of-pocket costs and the impact of prescription drug coverage

Medical Research: What are the main findings?

Dr. Barnes: We found that patients with prescription drug coverage (Medicare Part D) had significant cost savings when choosing dabigatran over warfarin.  This is primarily because of the reduction in both types of stroke as well not needing to have frequent blood draws, as are required by warfarin.  However, when patients do not have prescription drug coverage, the costs for dabigatran are quite high.  Continue reading

Study Compares Anticoagulation Risk Scores in Atrial Fibrillation

H.A. (Hendrika) van den Ham PharmD Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University The Netherlands.MedicalResearch.com Interview with:
H.A. (Hendrika) van den Ham PharmD

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences
Utrecht University
The Netherlands.

Medical Research: What is the background for this study? What are the main findings?

Dr. van den Ham: Atrial fibrillation (AF) is associated with a substantial risk of ischemic stroke and thromboembolism. The CHADSand the CHA2DS2-VASc risk scores are developed to guide the decision to prescribe anticoagulants. Recently a new clinically-based risk score, the ATRIA study risk score, was developed. We compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores in a large, independent, community-based cohort of Atrial fibrillation patients in the United Kingdom. We found that the ATRIA score more accurately identified low risk patients that the CHA2DS2-VASc score assigned to higher risk categories.  Such reclassification of stroke risk could prevent overuse of anticoagulants in very low stroke risk patients with Atrial fibrillation.

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Pulmonary Embolism: Hospitalizations Rise, Mortality Decreases

Karl Minges, MPH PhD Candidate Yale Graduate School of Arts & Sciences Yale School of Nursing Research Associate | Yale-New Haven Hospital Center for Outcomes Research & Evaluation (CORE) McDougal Graduate Career Fellow | Yale Office of Career Strategy

Karl Minges

MedicalResearch.com Interview with:
Karl Minges, MPH PhD Candidate
Yale Graduate School of Arts & Sciences
Yale School of Nursing
Research Associate | Yale-New Haven Hospital Center for Outcomes Research & Evaluation (CORE)
McDougal Graduate Career Fellow | Yale Office of Career Strategy

 

Medical Research: What is the background for this study? What are the main findings?

Response: Pulmonary embolism, caused by a sudden blockage in the lung artery, is thought to be among the most treatable and preventable causes of death. This has been precipitated by several recent diagnostic and therapeutic advancements that have broadened the range of options for diagnosis, treatment, and management for pulmonary embolism in the past decade. In fact, the public health burden of pulmonary embolism is so great that the U.S. Surgeon General issued a Call to Action to prevent venous thromboembolism, comprising deep vein thrombosis and pulmonary embolism in 2008.

Despite recent diagnostic and therapeutic advances in pulmonary embolism treatment and prevention, little is known regarding the national trends of pulmonary embolism among older adults – a population that is adversely at risk. In this study, we identified the recent trends in pulmonary embolism hospitalizations and outcomes, such as in-hospital, 30-day and 6-month mortality using a 100% sample of Medicare beneficiaries from 1999 to 2010. We examined instances where pulmonary embolism was the primary or most serious reason for which the patient was in the hospital. Trends by age, sex, and race cohorts were also examined.

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EE Stents for PCI: Benefits and Risks of Extending Dual Antiplatelet Therapy

Laura Mauri, MD, MSc Division of Cardiovascular Medicine, Department of Medicine Brigham and Women’s Hospital Boston, MA 02115MedicalResearch.com Interview with:
Laura Mauri, MD, MSc
Division of Cardiovascular Medicine,
Department of Medicine
Brigham and Women’s Hospital
Boston, MA 02115

 Medical Research: What is the background for this study? What are the main findings?

Dr. Mauri: The Dual Antiplatelet Therapy (DAPT) Study, the largest randomized controlled trial to date comparing different durations of dual antiplatelet therapy (thienopyridine plus aspirin) after coronary stenting, found that patients who were free from major ischemic or bleeding events at 1 year after coronary stenting (either drug-eluting [DES] or bare metal [BMS]), and who were compliant with their antiplatelet therapy, experienced significant reductions in stent thrombosis and myocardial infarction (MI) but increases in moderate or severe bleeding when treated with 30 months of thienopyridine plus aspirin, as compared with 12 months. We analyzed these outcomes in a post hoc analysis of the subset of patients who received everolimus-eluting stents (EES) in the DAPT Study, because EES were the most frequently used stent in the study, and because data suggest that EES may have lower rates of stent thrombosis when compared with paclitaxel-eluting stents. We found that 30 months of dual antiplatelet therapy after coronary stenting (compared to 12 months) was associated with reduced rates of stent thrombosis and MI, no difference in a composite outcome of death, MI and stroke, and increased rates of moderate or severe bleeding.

As found in the primary analysis of the DAPT Study, 30 months of dual antiplatelet therapy was associated with increased all-cause mortality, largely due to increased non-cardiovascular mortality. Bleeding-related deaths accounted for a minority of these deaths, where as cancer-related deaths in patients with pre-existing cancer diagnoses accounted for the majority of the mortality difference.

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Which Patients on Warfarin Need Repeat CT Scan after Head Injury?

MedicalResearch.com Interview with:
Dr Lim Beng Leong MBBS, MRCS (A&E), FAMS

Jurong Health Services
Emergency Department, Singapore 

Medical Research: What is the background for this study? What are the main findings?

Dr. Leong: It is common in the emergency department to see patients with warfarin who suffer a minor head injury (HI) with GCS >13. It is standard practice according to international guidelines to perform a plain CT scan of the head. What is contentious in the literature is the subsequent management of those patients with a normal initial CT scan. Practice is heterogeneous and includes a mandatory second CT scan at 24 hours mark or observation and repeat CT scan at the discretion of the attending doctor.

We have found in our study that the “observe and repeat CT scan for symptomatic cases” approach only was safe as abnormal second CT scans were rare (1 in 295 cases). We traced the patients’ course 2 weeks post discharge and none of the patients were re-admitted for reasons of delayed intra-cranial hemorrhage (ICH).

However, the cohort of patients consist largely of geriatric patients with falls. More than 50% of these patients were hospitalized for more than 3 days; the longest of 2-3 weeks. They were likely to have various reasons that required longer hospitalizations apart from observation for delayed ICH, such as assessing for risk, etc.

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Switching to Prasugel in Plavix Non-Responders Improved PCI Outcomes

MedicalResearch.com Interview with:
Renato Valenti, MD
David Antoniucci, MD
Cardiology Department; Careggi Hospital
Florence; Italy

Medical Research: What is the background for this study?

Response: Previous data have shown that high residual platelet reactivity in patients receiving clopidogrel is associated with high risk of ischemic events and cardiac death after PCI at short-  and long-term follow-up. Clopidogrel nonresponders patients of  the  REsponsiveness to CLOpidogrel and StEnt thrombosis (RECLOSE-2) ACS study received an increased dose of clopidogrel or switched to ticlopidine under light transmittance aggregometry (LTA) adenosine diphosphate  (ADP) test guidance. Despite some decrease of ADP test after treatment adjustment, there was no improvement on clinical outcome. Currently no evidence exists that the achievement of an optimal platelet aggregation inhibition in clopidogrel nonresponders  modifies  the risk profile of  these patients. The RECLOSE-3  study invesigated if a new antiplatet therapy with prasugrel in clopidogrel nonresponders can modify the risk profile of these patients and improve the outcome in term of cardiac mortality.

From the RECLOSE-3 registry we identified  302 consecutive  patients who were clopidogrel nonresponders.  Nonresponders  switched to prasugrel therapy.  Due to the nonrandomized study design the clinical outcome of clopidogrel nonresponders switched to prasugrel (from RECLOSE-3 study) was compared with the historical cohort of clopidogrel nonresponders of the RECLOSE-2 ACS (248 patients)  study. The primary endpoint of the study was cardiac mortality. The 2-year cardiac mortality rate was  4.0% in the RECLOSE-3 group and 9.7% in the RECLOSE-2 group (p=0.007). The difference in 2-year cardiac mortality remained also considering exclusively patients  with ACS on admission: 3.2% and 9.7%, respectively, p=0.023.At the final model of multivariable analysis, prasugrel treatment was inversely related to the risk of  2-year cardiac death (HR 0.32; p=0.036)  after adjusting for ACS and other well known covariates related to the outcome.

Medical Research: What are the main findings?

Response: The main finding of the RECLOSE-3 study is that nonresponsiveness to clopidogrel may be a “modifiable risk factor” for cardiac death after PCI. Prasugrel treatment overcomes nonresponsiveness to clopidogrel and results in thrombotic risk similar to the one of clopidogrel responders.

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PET Scan Using Tagged Fibrin Can Detect Hidden Blood Clots

Peter Caravan, PhD Co-Director, Institute for Innovation in Imaging (I3) Martinos Center for Biomedical Imaging Massachusetts General Hospital Associate Professor of Radiology Harvard Medical SchoolMedicalResearch.com Interview with:
Peter Caravan, PhD
Co-Director, Institute for Innovation in Imaging (I3)
Martinos Center for Biomedical Imaging
Massachusetts General Hospital
Associate Professor of Radiology
Harvard Medical School

Medical Research: What is the background for this study? What are the main findings?

Dr. Caravan: The motivation for this work was to develop a technique that would allow the detection of thrombus (clot) anywhere in the body after injection of a molecular probe called 64Cu-FBP8.  Current techniques for thrombus detection are limited to specific vascular territories.  In instances where the location of the thrombus is unknown or if there is suspicion of multiple thrombi, then multiple imaging tests must be performed.  We sought to develop a test that could be used to find clots anywhere:  brain, thorax, abdomen, legs and in arteries, veins, or the cardiac chambers.  In addition to whole body thrombus detection, we sought a technique that could address some of the limitations with current thrombus imaging techniques.  For example computed tomography (CT), which is used to detect pulmonary emboli, requires a contrast agent that cannot be used in patients with poor kidney function.  Transesophageal echocardiography used to identify thrombus in the chambers of the heart requires that the patient be sedated.

Our approach is to use a small peptide that recognizes the protein fibrin, which is a key component of blood clots.  We tagged the peptide with an isotope of copper, Cu-64, that allows the peptide to be detected by positron emission tomography (PET). 64Cu-FBP8 binds specifically to fibrin but not to other proteins in the blood and this means that the uptake in the clot is high while background signal is very low.  We combined PET imaging which finds the clot with CT imaging or magnetic resonance imaging (MRI).  By overlaying the PET image with the CT or MRI image, we could precisely localize the clot within the We were interested to see if the age of the clot impacted our ability to detect it.  We imaged animals with a total of 42 arterial or venous clots and then the images were analyzed by two reviewers who had no prior knowledge of the location of the clot.  Overall the accuracy was 98% for detection.

Another key finding was that the uptake of 64Cu-FBP8 strongly correlated with the amount of fibrin in the clot and that younger, fresher clots had more fibrin than older clots.  This could be very useful in distinguishing newer clots which may be the source of cardiovascular events from older, clots that may pose less risk.

We also showed using combined PET-MRI that we could detect multiple blood clots in the animal in a single whole body scan.  The procedure involves a single intravenous administration of 64Cu-FBP8 and clots in the deep veins of the legs or in the carotid arteries were readily detected.

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Some Heart Failure Patients Without AFib May Benefit From Anticoagulation

Line Melgaard MSc. Industrial Medicine, PhD student AALBORG Univerity Hospital Thrombosis Research Center Aalborg Aalborg Hospital Science and Innovation Center Aalborg DenmarkMedicalResearch.com Interview with:
Line Melgaard MSc. Industrial Medicine, PhD student
AALBORG Univerity Hospital
Thrombosis Research Center Aalborg
Aalborg Hospital Science and Innovation Center
Aalborg Denmark

Medical Research: What is the background for this study? What are the main findings?

Response: In recent years, use of the CHA2DS2-VASc score in predicting ischemic stroke, thromboembolism, and death has extended beyond the original disease state (atrial fibrillation) for which it was proposed. In addition, it is recognized that the cluster of multiple stroke risk factors included within the CHA2DS2-VASc score increases the risk of ischemic stroke, thromboembolism, and death, whether or not atrial fibrillation is present. Thus, there is a need to study the extent to which concomitant atrial fibrillation modifies the pattern of the association between CHA2DS2-VASc score and the risk of ischemic stroke, thromboembolism, and death in patients with heart failure.

  • Our principal findings were that patients with heart failure had a high risk of ischemic stroke, thromboembolism, and death, whether or not atrial fibrillation was present.
  • Second, the CHA2DS2-VASc score was able to modestly predict these endpoints, and had a moderately high negative predictive value at 1-year follow-up.
  • Third, at high CHA2DS2-VASc scores (≥4), patients with heart failure without atrial fibrillation had high absolute risk of ischemic stroke, thromboembolism, and death, and the absolute risk increased in a comparable manner in patients with heart failure with and without atrial fibrillation, exhibiting a clear dose-response relationship. Indeed, the absolute risk of thromboembolic complications was higher among patients without atrial fibrillation compared to patients with concomitant atrial fibrillation at high CHA2DS2-VASc score (≥4).

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Triple Anticoagulation Therapy Raises Bleeding Risk in Elderly Patients with AFib and Heart Attack

Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North CarolinaMedicalResearch.com Interview with:
Connie N. Hess, MD, MHS
Duke Clinical Research Institute
Duke University
Durham, North Carolina

Medical Research: What is the background for this study? What are the main findings?

Dr. Hess: Guidelines recommend the use of anticoagulation for thromboembolic prophylaxis in atrial fibrillation and also recommend use of dual antiplatelet therapy to reduce cardiovascular events after myocardial infarction and percutaneous coronary intervention.  The use of triple therapy in patients with indications for DAPT and anticoagulation is challenging due to the increased bleeding risk associated with this regimen.  The optimal antithrombotic regimen in this population has not yet been defined.

This study specifically focused on older patients, a population that is at greater risk for Atrial Fibrillation-related stroke and recurrent events after MI but also higher risk for bleeding. Despite a growing population of older patients with indications for triple therapy, these patients have been underrepresented in clinical trials and are therefore understudied.

We found that relative to DAPT, patients on triple therapy had a similar risk of 2-year major adverse cardiac events but a significantly increased risk of bleeding requiring hospitalization, including greater risk of intracranial hemorrhage.

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DVT: Clot Removal Outcomes Better In Hospitals With Higher Volume of Procedures

Riyaz Bashir MD, FACC, RVTProfessor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140MedicalResearch.com Interview with:
Riyaz Bashir MD, FACC, RVT
Professor of Medicine
Director, Vascular and Endovascular Medicine
Department of Medicine
Division of Cardiovascular Diseases
Temple University Hospital
Philadelphia, PA 19140

Medical Research: What is the background for this study?

Dr. Bashir: Catheter-based thrombus removal also known as Catheter Directed Thrombolysis (CDT) is a minimally invasive therapeutic intervention that has evolved over the past two decades to reduce the incidence of post thrombotic syndrome (PTS), a very frequent and disabling complication of proximal deep vein thrombosis (DVT). Catheter-based thrombus removal has been shown to reduce this lifestyle limiting complication of DVT and as a result we have observed a significant increase in the utilization rates of CDT across United States. Recent nationwide observational data suggests that higher adverse events such as intracranial hemorrhage rates and need for blood transfusions are seen with CDT use.  Nonetheless specific reasons for these findings have not been explored prior to this study.

Medical Research: What are the main findings?

Dr. Bashir: This study showed a significant inverse relationship between the institutional Catheter-based thrombus removal volumes and safety outcomes like death and intracranial hemorrhage. The institutions with higher volume of CDT cases annually (greater than or equal to 6 cases) were associated with lower in-hospital mortality rates and lower intracranial hemorrhage rates as compared to institutions, which performed less than 6 cases annually. This study also showed that at high volume institutions there was no difference in terms of death or intracranial bleeding rates between CDT plus anticoagulation versus anticoagulation alone.

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Atrial Fibrillation Increases Risk of Stroke After TAVR

Prof. Johan Bosmans Interventional cardiologist University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, BelgiumMedical Research Interview with:
Prof. Johan Bosmans

Interventional cardiologist
University Hospital Antwerp, Wilrijkstraat 10, 2650,
Edegem, Belgium

MedicalResearch: What is the background for this study? What are the main findings?

Prof. Bosmans : Transcatheter aortic valve replacement (TAVR) has become standard of care for patients who cannot undergo surgery. With this, it is important to ensure that the risks associated with TAVR be fully understood, and if possible prevented. Even at this stage of the adoption of TAVR, large trials continue to provide information to the clinician about how to select the right patients to ensure the best possible outcomes. The ADVANCE Study is a prospective, multicenter study that evaluated the use of TAVR in 1015 patients at 44 experienced TAVR centers, which was designed to reflect routine clinical practice.

We know that the risk of serious adverse events, such as stroke or transient ischemic attack (TIA), in post-TAVR patients can vary based on the timing before and after the procedure. A patient’s baseline demographics and medical history can affect their risk of procedure-related events as well as long-term outcomes. The manipulations required crossing the aortic valve and appropriately positioning any type of TAV has been thought to be related to procedural stroke events. Therefore, we performed a multivariable analysis looking for predictors of stroke – or stroke and TIA at 3 unique time periods (periprocedural, early and late) following TAVR.

The most striking result from our analyses was that we were not able to identify any predictors of periprocedural (either during the procedure or on the day after) stroke, illustrating this very multifactorial etiology. We were able to show that being female, experiencing acute kidney injury or a major vascular complication positively predicted stroke during the early (2-30 days post procedure) time period. When we combined the outcome of stroke or TIA, we found that a history of prior atrial fibrillation (AF) was also a predictor. The only late predictor (day 31-730 post-procedure) of stroke was a history of coronary artery bypass grafting, which could reflect the patients’ risk of vascular disease.

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Antidepressants Plus NSAIDS May Increase Risk of Bleeding in Brain

MedicalResearch.com Interview with:
Byung-Joo Park, MD, MPH, PhD
Professor
Department of Preventive Medicine
Seoul National University College of Medicine

Medical Research: What is the background for this study? What are the main findings?

Response: Antidepressants and NSAIDs are each thought to increase the risk of abnormal bleeding.  However, previous studies found neither antidepressants nor NSAIDs alone to be associated with an increased risk of intracranial haemorrhage.  Our research found that combined use of NSADIs in antidepressant users showed the increased relative risk of intracranial haemorrhage risk within the initial 30-days of combined use.

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Study Confirms Validity of Bova Score For Pulmonary Embolism Patients

MedicalResearch.com Interview with:
David Jimenez PhD, FCCP
Respiratory Department and Medicine Department
Ramon y Cajal Hospital IRYCIS, and Alcala de Henares University
Madrid Spain

Medical Research: What is the background for this study? What are the main findings?

Dr. Jimenez: Normotensive patients that have an estimated high-risk for pulmonary embolism (PE)-related complications (i.e., intermediate-risk PE) might benefit from surveillance in an intensive care setting or from the administration of specific advanced therapy. The Bova score was developed for identifying these patients. This study confirms the validity and reproducibility of the Bova score.

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Retrievable Inferior Vena Cava Filters May Be Removed Despite Long Dwell Time

Robert J. Lewandowski, MD FSIRAssociate Professor of Radiology Director of Interventional Oncology Department of Radiology Northwestern University Feinberg School of MedicineMedicalResearch.com Interview with:
Robert J. Lewandowski, MD FSIR
Associate Professor of Radiology
Director of Interventional Oncology
Department of Radiology
Northwestern University Feinberg School of Medicine

Medical Research: What is the background for this study? What are the main findings?

Response: Retrievable inferior vena cava filters (rIVCF) were designed to provide temporary prevention from pulmonary embolism and then be removed when no longer needed. With permanent United States Food and Drug Administration (FDA) indication, these devices now account for the majority of IVC filters placed. Most rIVCFs placed are never removed because of poor clinical follow up, failed retrieval procedures, or patients not being offered the opportunity for filter removal secondary to prolonged dwell time; the latter has previously been correlated with retrieval failure.

Retrievable IVCFs appear to be subject to greater device related complications (e.g., filter penetration of the IVC, filter migration, filter fracture) relative to permanent devices; furthermore, the rates of these complications appear to increase with filter dwell time. This prompted the FDA to issue a 2010 safety alert urging removal of rIVCFs once they are deemed no longer necessary.

In the present study, we sought to determine whether rIVCF dwell time affects technical success of the retrieval procedure. Over a six-year period, 648 retrieval procedures were performed at our institution, with filter dwell times ranging from 0-108 months. We found that filter dwell time did not negatively impact IVC filter retrieval success nor did it increase our adverse events from the retrieval procedure. With advanced, adjunctive IVC filter retrieval techniques, rIVCFs can be safely and reliably removed despite long dwell times.

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Duration of Anticoagulation After Primary Pulmonary Embolism Clarified

Professor Francis Couturaud, MD, PhD Department of Internal Medicine and Chest Diseases University Hospital Center of Brest Brest, FranceMedicalResearch.com Interview with:
Professor Francis Couturaud, MD, PhD
Department of Internal Medicine and Chest Diseases
University Hospital Center of Brest
Brest, France

Medical Research: What is the background for this study? What are the main findings?

Dr. Couturaud: Patients who have completed 3 to 6 months of anticoagulation for a first episode of pulmonary embolism that was not provoked by a major transient risk factor, such as surgery or prolonged immobilization, have a high risk of recurrent venous thromboembolism after stopping anticoagulation. In this high-risk population, extending anticoagulation beyond 3 to 6 months is associated with a major reduction in recurrences as long as the treatment is continued. However, whether this benefit is maintained thereafter remains uncertain, as in most previous studies, patients were not followed after treatment discontinuation. In addition, while extending anticoagulation is very effective in preventing recurrent venous thromboembolism, anticoagulation is also associated with an increased risk of bleeding. Therefore, in patients with a first episode of unprovoked pulmonary embolism, the optimal duration of anticoagulation remains uncertain.

In the PADIS-PE multicenter, double-blind, randomized trial that included 371 patients with a first episode of unprovoked pulmonary embolism initially treated during 6 months, we aimed to evaluate the benefit and risk of an additional 18 months of warfarin therapy versus placebo during the 18-month study treatment period and during an additional 2 years of follow-up after study treatment discontinuation.

The main findings are the followings: during the study treatment period, we found a 80% reduction in the relative risk of recurrent venous thromboembolism or major bleeding, mainly driven by the 90% risk reduction of recurrences; however, during the post-treatment follow-up period of two years, the benefit was lost, and the risks of recurrent venous thromboembolism and major bleeding were not different between the 2 groups. In addition, recurrent venous thromboembolism occurred as pulmonary embolism in 80% of cases (8% were fatal) and were unprovoked in 90% of cases.

Medical Research: What should clinicians and patients take away from your report?

Dr. Couturaud: Our study provides convincing result that extended but limited duration of anticoagulation does not improve the long-term prognosis of a first episode of unprovoked pulmonary.

The consequences for clinicians are the followings:

First, only two options of management should be discussed: either a conventional duration of 3 to 6 months or an indefinite duration of anticoagulation.

Second, more than ever, the individual risk factors of recurrent VTE if anticoagulation is stopped and risk factors of bleeding if anticoagulation is continued should be carefully identified and weighted in order to propose the most adequate long-term secondary prevention (long-term anticoagulation or specific prophylactic counseling in high-risk situations). This evaluation should also included patient’s preference.

Third, the benefit risk ratio of indefinite anticoagulation should be serially evaluated in these patients not only if indefinite anticoagulation is decided but also if anticoagulation is stopped as patient’s profile will change over the time (age, additional comorbidities, etc.) and in order to determine if anticoagulation should be stopped or started again.

For the patients, once the first episode of unprovoked pulmonary embolism, they should be informed about their high risk of recurrent venous thromboembolism if anticoagulation is stopped and their risk of bleeding if anticoagulation is continued. They also should be informed that recurrent venous thromboembolism occurs more often as pulmonary embolism; in this setting, patients should be informed about clinical symptoms of pulmonary embolism but also of deep vein thrombosis and the links between these two entities. This will help people to express their preferences.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Couturaud: : The first issue is to identify, among patients with unprovoked venous thromboembolism, those who have a lower risk of recurrence that may not justify indefinite anticoagulation. Several predictive scores, combining clinical variables such at gender, age, and tests such as D-dimer have been derived but prospective validation is not yet available.
The second issue is to explore long-term secondary thrombo-prophylaxis strategies with a lower risk of bleeding and a similar efficacy. This is currently the case with aspirin and low dose of Direct Oral Anticoagulants. However, additional studies are needed to determine if such strategies have a better benefit risk ratio than conventional anticoagulation.

Citation:

Professor Francis Couturaud, MD, PhD, & Department of Internal Medicine and Chest Diseases (2015). Duration of Anticoagulation After Primary Pulmonary Embolism Clarified 

RE-VERSE AD: Anticoagulant Effect of Dabigatran Reversed By New Drug

MedicalResearch.com Interview with:
Dr. Charles Pollack Jr., MA, MD, FACEP
Thomas Jefferson University
Clinical Professor of Emergency Medicine
Philadelphia, PA 19107

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Pollack: There are currently no approved specific reversal agents for non–vitamin K antagonist oral anticoagulants. Idarucizumab, an antibody fragment, was developed to specifically reverse the anticoagulant effects of the oral thrombin inhibitor, dabigatran.

RE-VERSE AD is an ongoing, global Phase III patient study initiated in 2014 to investigate idarucizumab in emergency settings in patients taking dabigatran. We undertook this prospective cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who either presented with serious bleeding (group A) or required an urgent invasive procedure (group B) which could not be delayed by eight hours. We intentionally designed the study with very broad inclusion criteria to reflect the types of patients who would require urgent anticoagulant reversal in real-world emergency settings.

The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the determination at a central laboratory of the dilute thrombin time or ecarin clotting time. We also diligently collected clinical outcomes as secondary outcomes, being conscious that these may vary considerably due to the heterogeneity of the patients we included in the study.

In our publication in the New England Journal of Medicine, we present the first results from the study, in an interim analysis of the data from the first 90 patients. The data showed that idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in 88 to 98% of the patients who had had elevated clotting times at baseline. The reversal effect was evident within minutes. There were no safety concerns related to idarucizumab among the 90 patients involved in this study – including patients who were given idarucizumab on clinical grounds but were later found to have had normal results on clotting tests at baseline. This is consistent with the experience from the more than 200 volunteers who were administered idarucizumab in previous studies.

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Anticoagulation Bridge Therapy May Be Unnecessary For Low Risk Venous Thromboembolism Patients


MedicalResearch.com Interview with:
Nathan Clark, PharmD
Clinical pharmacy supervisor, anticoagulation and anemia management services and
Thomas Delate, PhD
Clinical research scientist
Kaiser Permanente Colorado

MedicalResearch: What is the background for this study? What are the main findings?

Response: Patients with a history of blood clots are commonly prescribed warfarin, an anticoagulant, to decrease the body’s ability to form additional clots. Clinicians typically stop the use of warfarin in patients to reduce the risk of serious bleeding when invasive procedures, such as colonoscopy or orthopedic surgery are scheduled. However, when warfarin interruptions occur, patients are exposed to an increased risk of blood clots three to five days before and five or more days after invasive procedures. Bridge therapy with another, faster acting anticoagulant is often initiated in an attempt to reduce the patients’ risk for developing blood clots during that gap.

Bridging has been a part of standard therapy for venous thromboembolism (VTE) patients undergoing invasive procedures for many years. But only limited data outlining the rates of bleeding and VTE recurrence were available to help clinicians analyze the risks and benefits of bridge therapy.

We examined the electronic medical records of 1,178 patients with VTE who underwent 1,812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin therapy. Study patients were categorized into three groups based on their annual risk of VTE recurrence without anticoagulant therapy. Within those groups, a total of 555 patients – 28.7 percent of low-risk, 33.6 percent of moderate-risk and 63.2 percent of high-risk patients – received bridging anticoagulant therapy. The 1,257 patients who did not receive bridge therapy interrupted their warfarin use and received no other anticoagulants during the perioperative period. The use of bridge therapy resulted in a 17-fold higher risk of bleeding without a significant difference in the rate of blood clot formation compared to patients who didn’t receive bridge therapy. In addition, there were no significant differences in the rates of blood clot occurrence or death between the bridged and non-bridged patient groups. Continue reading

Some Birth Control Pills Have Slightly Higher Risk Of Venous Thromboembolism

MedicalResearch.com Interview with:
Yana Vinogradova, Research Fellow
Division of Primary Care
School of Medicine
University of Nottingham

Medical Research: What is the background for this study? What are the main findings?

Response: Combined oral contraceptives are an effective method of birth control but do have measurable side effects.  One – common to all combined contraceptives and sometimes fatal – is an increased risk of venous thromboembolism (VTE).  A number of earlier studies investigated VTE risks for different types of hormonal contraceptives, but all were performed some years ago or had insufficient data to analyse newer preparations, while some included only healthy users and others did not adequately control for lifestyle and health issues.  The data used for this study were representative of the UK population and covered all currently prescribed drugs, with results adjusted for the widest possible range of available relevant factors.

We found that the venous thromboembolism risks of combined oral contraceptives appear to fall into two distinct groups.  Newer drugs containing gestodene, desogestrel, drospirenone or cyproterone were associated with risks of VTE between 1.5 and 1.8 times higher than both the older compositions containing norethisterone or levonorgestrel and the relatively newer norgestimate.  While our findings are statistical associations between different compositions and venous thromboembolism risks, they do represent more comprehensive and reliable information for doctors making evidence-based prescribing decisions. Continue reading

Negative Ultrasound Study Can Rule Out Upper Extremity DVT

MedicalResearch.com Interview with:
Dott. Michelangelo Sartori

U.O. di Angiologia e Malattie della Coagulazione
Azienda Ospedaliera di Bologna
Policlinico Sant’Orsola Malpighi
Bologna

Medical Research: What is the background for this study? What are the main findings?

Response: The safety of withholding anticoagulation only on the basis of ultrasound imaging has not been evaluated in patients with suspected (Upper Extremity Deep Vein Thromobsis) UEDVT. The purpose of this management study was to evaluate the failure rate of ultrasound testing for UEDVT diagnosis in outpatients. Our data show that, similarly to the lower extremity, a negative complete ultrasound assessment of the upper extremity can safely exclude DVT. We found a 3-month VTE rate of 0.6% after a negative ultrasound and such figure is not different from the 3-month VTE incidence in management studies for lower limb DVT.  Thus anticoagulant therapy can be withheld for clinically suspected UEDVT after negative ultrasound examination without further testing in the ambulatory office setting.
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Coumarin Users at Higher Risk For Cerebral Microbleeds

MedicalResearch.com: Interview Invitation
S. Akoudad, MD Msc PhD candidate
Dep. Epidemiology, Radiology, Neurology
Erasmus MC, Rotterdam , the Netherlands

Medical Research: What are the main findings of the study?

Dr.  Vernooij: We found that compared to never users, coumarin users had a higher prevalence of deep or infratentorial microbleeds and probably also a higher incidence of any microbleeds. A higher maximum international normalized ratio (INR) was associated with deep or infratentorial microbleeds, and among coumarin users, a greater variability in INR was associated with a higher prevalence of microbleeds.

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Rivaroxaban For Venous Thromboembolism Prevention In Cancer Patients

MedicalResearch.com Interview with:
Prof Martin H Prins MD
Maastricht University Medical Centre, Maastricht, Netherlands

Medical Research: What are the main findings of the study?

Dr. Prins: Patients with active cancer, i.e. a cancer that was diagnosed or treated within 6 months before the episode, that was recurrent or metastatic, or that was diagnosed during treatment, who had a symptomatic episode of venous thromboembolism, were included in this pooled subgroup analysis of the Einstein DVT and PE studies. The incidence of recurrent venous thromboembolism was similar between groups. It occurred in 16 (5%) of 354 patients allocated to rivaroxaban and 20 (7%) of 301 patients allocated to enoxaparin and vitamin K antagonist (hazard ratio [HR] 0•67, 95% CI 0•35 to 1•30). Clinically relevant bleeding was also similar and occurred in 48 (14%) of 353 patients receiving rivaroxaban and in 49 (16%) of 298 patients receiving standard therapy (HR 0•80, 95% CI 0•54 to1•20). However, major bleeding was less frequent among rivaroxaban recipients and occurred in eight (2%) of 353 patients receiving rivaroxaban and in 15 (5%) of 298 patients receiving standard therapy (HR 0•42, 95% CI 0•18 to 0•99). Mortality was also similar.
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NSAIDS May Increase Risk of Venous Thromboembolism

Patompong Ungprasert, MD Division of Rheumatology Mayo Clinic, MN
MedicalResearch.com Interview with:

Patompong Ungprasert, MD
Division of Rheumatology
Mayo Clinic, MN

Medical Research: What are the main findings of the study?

Dr. Ungprasert: We find a statistically significant association between NSAIDs (non-steroidal anti-inflammatory drugs) use and VTE (venous thromboembolism).
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